Dr Sally Choe, Director, Office of Generic Drugs, outlined the actions that OGD has taken for outreach to stakeholders, citing the many workshops and seminars in which OGD participated. She provided a view of the GDUFA regulatory science initiatives, including guidance on complex products, internal alignment on complex issues, confidence in generic substitution, review tool development,
(Westbury, NY – May 2019) Lachman Consultant Services, Inc. (“Lachman Consultants”), a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide, will be participating as a Conference Sponsor at the 25th annual Medicines for Europe and IGBA Conference. Entitled “Committing to Global Health – Balancing Access and Sustainability,” this year’s event is focused on generic,
(Westbury, NY – April 2, 2019) Fran Zipp, President and CEO of Lachman Consultants, Inc. a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that comprises Lachman’s Compliance Practice Group,
FDA notes on its User Fee web page (here) that the key date for acceptance of NDAs, BLAs, and ANDAs will be dictated by the first date that FDA could accept fees under the appropriation (after the shut down was over) which is January 28, 2019. The Agency gives the following advice as to how it will treat fee-paying applications and time periods for which fees must be paid (if not submitted at time of original submission of the application) (please see below):
- For ANDAs transmitted to FDA during the lapse period,
The Drug Price Competition and Patent Term Restoration Act of 1984 requires the FDA to publish a notice of all approved products and their marketing status. The FDA satisfies this requirement by publication of the drug products in the Orange Book; the FDA will publish information in the active section (if the product is currently being marketed) or the discontinued section (if it not being marketed for other than safety or efficacy reasons).
With 5 working days left in January, and despite the turmoil this month has seen, we stand at 58 Full approvals and 17 Tentative approvals reported on the FDA All Approvals page (here) through January 24, 2019.
Looking at the first quarter approvals (October thru December), there were a total of 278 full approvals which,
Today, the FDA published its required Activities Reports of the Generic Drugs Program (FY 2019) – FDARA Title VIII, Sections 807 and 805 (here). These reports are published quarterly, as required by law, and outline the following activities: ANDAs subject to priority review, ANDAs with a competitive therapy designation (CTD), and pending suitability petitions (a first-time report issued by the FDA).
While concluding its 40th Anniversary Celebration Year with the start of 2019, Lachman Consultants recently announced participation as Business Exposition Sponsor of ACCESS! 2019, the annual meeting of the Association for Accessible Medicines (AAM).
(Westbury, NY – January 2019) Lachman Consultant Services, Inc. a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide will be a prominent participant at ACCESS!
After thinking about our blog post yesterday (here https://www.lachmanconsultants.com/2019/01/the-20-day-window-catch-how-will-it-play-out-and-other-questions/), it now becomes clear why the update to receipts and approvals for the December posting of the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm375079.htm) left out the number of December receipts. It is because the FDA has not yet decided how to handle application receipts that came in after the shutdown on December 22,
The unprecedented length of the government shutdown has a lot of people scratching their heads about lots of things. From a personal perspective, I have heard that FDAers are still getting paid (Commissioned Corps and civil servants) but the unknown is, for how long? When will the user fee money really run out? Has FDA been able to use the money that they collected for the applications submitted between October 1,
It will only be weeks until the User Fee carryover money for all the User Fee programs runs out. While Commissioner Gottlieb is doing his best to shuffle resources, the Agency will likely be up the perpetual tributary without any physical means of propulsion soon.
Because the Agency cannot accept any new fee-paying applications since the shutdown started,
I woke up this morning to some sad news. Bob West, former Public Health Service officer who spent some 40+ years in government service, passed away yesterday. For those of you in the drug industry, the name Bob West meant a caring, rational, helpful individual.
Bob came to OGD after a stint with the Public Health Service’s hospitals and clinics and then after a number of years in New Drugs.
In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note:
“We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.
The Office of Generic Drugs (OGD) has taken great pride in meeting all of its GDUFA goals (including most, if not all, ANDA review goal dates). But, Houston, we may have a problem!
Here are some facts that may have the OGD worrying into the future:
- December is typically one of the largest months for submissions.
OGD fully approved 69 original ANDAs and tentatively approved 31 for a total approval action of 100. This is actually 18 more than we were able to spot on the FDA all approvals actions in our January 3rd post (here). Not bad, considering the short month with vacations and the Federal government shutdown that started December 22 so actually represents a better result than what we anticipated.